Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone

NCT ID: NCT00004645

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-01-31

Brief Summary

OBJECTIVES:

I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by disease type; each stratum is randomized separately.

The first group of patients receives a true plasma exchange using continuous-flow centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7 exchanges.

The second group receives a sham plasma exchange with no centrifugation every 2 days for a total of 7 exchanges.

Patients cross to the alternate therapy if there is less than a moderate improvement by day 14. The treatment decision is based on a blinded neurologic assessment.

Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not allowed.

Patients are followed at 1 and 6 months after the last exchange.

Conditions

Acute Disseminated Encephalomyelitis; Devic's Syndrome; Marburg's Variant of Multiple Sclerosis; Balo's Concentric Sclerosis; Acute Transverse Myelitis

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Plasma exchange

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Acute neurologic deficit markedly affecting consciousness, language, or brainstem/spinal cord function, i.e., aphasia, paraplegia, coma, quadriplegia, hemiplegia, severe organic brain syndrome
• Deficit unresponsive to 5 days of high-dose intravenous methylprednisolone (MePRDL), as follows: deficit duration of 21 days to 3 months AND no improvement 14 days after beginning MePRDL OR deficit duration of 12 to 20 days AND continued deterioration after completion of MePRDL
• No chronically progressive demyelinating disease
• No HIV-associated demyelinating syndrome
• No progressive multifocal leukoencephalopathy
• No optic neuritis

--Prior/Concurrent Therapy--

• No more than 3 months of prior steroid therapy Failure on prior MePRDL required Minimum dose 7 mg/kg per day for 5 days
• At least 6 weeks since other immunosuppressives, e.g., cyclophosphamide, azathioprine, cyclosporine

--Patient Characteristics--

• Renal: Creatinine less than 1.5 mg/dL
• Cardiovascular: No hypovolemia; no infarction; no vasculitis; no other major systemic cardiovascular illness
• Pulmonary: No major respiratory illness
• Other: No infection, including hepatitis or human immunodeficiency virus; no recent intravenous drug abuse; no high-risk sexual behavior; no cardiac, cerebrovascular, or autonomic dysfunction that would increase risk of hypotension; no other major systemic illness that would preclude protocol therapy; no pregnant or nursing women; negative serum pregnancy test required of fertile women; effective contraception required

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: lead

Principal Investigators

Brian G. Weinshenker

Role: STUDY_CHAIR

Mayo Clinic

Other Identifiers

MAYOC-29493

Identifier Type: -

Identifier Source: secondary_id

199/11693

Identifier Type: -

Identifier Source: org_study_id